Global Regulatory Affairs Leader for Medical Devices

Braccomedtech; Minnesota; On-site; USD 100,000 - 130,000; Full time

Job summary

A medical device company located in Minnesota is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies for products and processes. The role requires at least 7 years of experience in medical device regulatory affairs, with responsibilities that include managing 510(k) submissions and communicating with regulatory agencies. The ideal candidate will demonstrate effective skills in project management and problem-solving while ensuring compliance with relevant regulations.

Qualifications

• 7+ years of experience in medical device Regulatory Affairs.
• Experience with 510(k), EU CE Marking, and Health Canada submissions.
• Strong written and verbal communication skills.
• Ability to develop clear reports and communicate complex information.

Responsibilities

• Develop and execute regulatory plans for product submissions.
• Coordinate support for global registrations.
• Communicate with regulatory agencies and lead meetings.
• Maintain all regulatory files and documentation.

Skills

Regulatory Affairs expertise

Communication skills

Critical thinking

Project management

Education

Bachelor’s degree

Job description

A medical device company located in Minnesota is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies for products and processes. The role requires at least 7 years of experience in medical device regulatory affairs, with responsibilities that include managing 510(k) submissions and communicating with regulatory agencies. The ideal candidate will demonstrate effective skills in project management and problem-solving while ensuring compliance with relevant regulations.